Phenytoin Sodium Flynn 100mg Hard Capsules
Epanutin® 100mg Hard Capsules
(phenytoin sodium)
Read all of this leaflet carefully before you
start taking this medicine
x Keep this leaflet. You may need to read it
again.
x If you have any further questions, ask your
doctor or pharmacist.
x This medicine has been prescribed for you.
Do not pass it onto others. It may harm
them, even if their symptoms are the same
as yours.
x If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
Your medicine is available in any of the above
two names, but will be referred to as
Phenytoin Hard Capsules throughout the
remainder of the leaflet.
In this leaflet:
1. What Phenytoin Hard Capsules are and what
they are used for.
2. Before you take Phenytoin Hard Capsules
3. How to take Phenytoin Hard Capsules
4. Possible side effects
5. How to store Phenytoin Hard Capsules
6. Further information
1. What Phenytoin Capsules are and what
they are used for.
Phenytoin Hard Capsules is one of a group of
medicines called anti-epileptic drugs; these
medicines are used to treat epilepsy.
Phenytoin Hard Capsules can be used to
control a variety of epileptic conditions, to
control or prevent seizures during or after brain
surgery or severe head injury. Phenytoin Hard
Capsules can also be used to treat trigeminal
neuralgia (facial nerve pain). You should ask
your doctor if you are unsure why you have
been given Phenytoin Hard Capsules.

Revision Date: 6th January 2014
Epanutin is a registered trademark of Parke,
Davis & Company LLC.

2. Before you take Phenytoin Hard Capsules
Do not take Phenytoin Hard Capsules
x If you are allergic (hypersensitive) to
Phenytoin, or any of the other ingredients of
Phenytoin Hard Capsules
Take special care with Phenytoin Hard
Capsules
Medicines are not always suitable for everyone.
Your doctor needs to know before you take
Phenytoin Hard Capsules if you suffer from or
have suffered in the past from any of the
following conditions:
x Liver disease
x Porphyria (an inherited disease that affects
haemoglobin biosynthesis).
A small number of people being treated with
anti-epileptics such as phenytoin have had
thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately
contact your doctor.
Serious skin side effects can rarely occur
during treatment with Phenytoin Hard
Capsules. This risk may be associated with a
variant in genes in a subject of Chinese or Thai
origin. If you are of such origin and have been
tested positively carrying this generic variant
(HLA-B*1502), discuss this with your doctor
before taking Phenytoin Hard Capsules.
Taking other medicines
Some medicines can affect the way
Phenytoin Hard Capsules work, or
Phenytoin Hard Capsules itself can reduce
the effectiveness of other medicines taken
at the same time. These include:
x Medicines used for heart and circulation
problems (dicoumarol, digitoxin,
amiodarone, furosemide, quinidine,
reserpine, warfarin and calcium channel
blockers e.g. dilitazem and nifedipine.

(leaflet continued overleaf)

(leaflet continued)

Remember: This medicine is only for you. Only
your doctor can prescribe Phenytoin Hard
Capsules for you. Never give it to anyone else.
They may harm them even if their symptoms
are the same as yours.

PP1/1380/V2

x Medicines used for epilepsy
(carbamazepine, lamotrigine, phenobarbital,
sodium valproate and valproic acid,
succinimides e.g. ethosuximide and
vigabatrin).
x Medicines used to treat fungal infections
(e.g. amphotericin B, fluconazole,
itraconazole, ketoconazole and
miconazole).
x Medicines used for tuberculosis and other
infections (chloramphenicol, isoniazid,
rifampicin, sulphonamides, doxycycline and
ciprofloxacin and nelfinavir).
x Medicines used for stomach ulcers
(omeprazole, sucralfate, the medicines
known as H2 antagonists e.g. cimetidine,
ranitidine, famotidine and some antacids).
x Medicines used for asthma and bronchitis
(theophylline).
x Medicines used for pain and inflammation
(phenylbutazone, salicylates e.g. aspirin
and steroids).
x Medicines used for sleeplessness,
depression and psychiatric disorders
(chlorodiazepoxide, clozapine, diazepam,
disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, trazodone,
tricyclic antidepressants fluvoxamine,
sertraline and viloxazine).
x Medicines used for diabetes (tolbutamide).
x Some hormone replacement therapies
(oestrogens), oral contraceptives (the birth
control pill).
x Medicines used for organ tissue
transplants, to prevent rejection
(ciclosporin)
x Medicines used for cancer (antineoplastic
agents)
x Muscle relaxants used for surgery
(neuromuscular blockers), some
anaesthetic drugs (halothane) and
methadone
x Some products available without a
prescription folic acid, theophylline,
vitamin D).
Your doctor may need to test the amount of
Phenytoin in your blood to help decide if any of
these medicines are affecting your treatment.

3. How to take Phenytoin Hard Capsules
It is best to take Phenytoin Capsules at the
same time each day.
Swallow the capsules whole, with plenty of
water.
Important information about some of the
ingredients of Phenytoin Hard Capsules
Phenytoin Hard Capsules contain lactose, a
type of sugar. If you have been told that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.
Driving and using machines
Phenytoin Hard Capsules may cause dizziness
or drowsiness, especially during the first few
weeks of treatment. If you experience these
symptoms, do not drive or use any tools or
machinery.
Ask your doctor or pharmacist for advice before
taking any medicine.
You should not take Phenytoin Hard Capsules if
you are breast-feeding
Pregnancy and Breast-feeding
If you think you might be pregnant, or are
planning to get pregnant, tell your doctor before
you take Phenytoin Hard Capsules
Taking Phenytoin Hard Capsules with food
and drink
Phenytoin Hard Capsules can be taken before
or after food and drinks. Drinking a lot of
alcohol can also affect the concentration of
Phenytoin in your blood.
Phenytoin Hard Capsules may also interfere
with certain laboratory tests that you may be
given.
The herbal preparation St John’s wort
(Hypericum perforatum) should not be taken at
the same time as this medicine. If you already
take St John’s wort consult your doctor before
stopping St John’s wort preparation.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required, these measures will help to
protect the environment.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adults
The amount of Phenytoin Hard Capsules
needed varies from one person to another.
Most adults need between 200 mg and 500 mg
a day, either as a single or divided dose.
Occasionally higher doses are needed.

Other side effects that may occur are:
x Effects on your nervous system:
Unusual eye movements, unsteadiness,
difficulty in controlling movements, shaking,
abnormal or uncoordinated movements,
slurred speech, confusion, pins and
needles or numbness, drowsiness,
dizziness, vertigo, sleeplessness,
nervousness, twitching muscles,
headaches and taste change.
x Effects on your skin: skin rash including
measles-like reactions which are mild.
x Effects on your stomach and intestines:
feeling sick, being sick and constipation.
x Effects on your blood and lymph
system: swelling of the lymph glands
x Effects on your liver and kidneys:
inflammation of the kidneys and liver, liver
damage (seen as yellowing of the skin and
whites of the eye).
x Effects on your reproductive system
and breasts: changes in the shape of the
penis, painful erection.
x Effects on hands, face and body:
changes in the hands with difficulty in
straightening the fingers, changes in facial
features, enlarged lips or gums, increased
or abnormal body or facial hair.
x Effects on medical tests: increased
levels of blood sugar, or decreased levels
of blood calcium, folic acid and vitamin D.
If you also do not get enough vitamin D in
your diet or from exposure to sunlight, you
may suffer from bone pain or fractures.
x Effects on your respiratory system:
problems breathing, inflammation of the
lining of the lung.
x Effects on your immune system:
problems with the body’s defence against
infection, inflammation of the wall of the
arteries.
x Effects on your bones: There have been
reports of bone disorders including
osteopenia and osteoporosis (thinning of
the bone) and fractures. Check with your
doctor or pharmacist if you are on longterm antiepileptic medication, have a
history of osteoporosis, or take steroids.

5. How to store Phenytoin Hard Capsules
Keep out of the sight and reach of children
Do not store above 25°C. Store in the original
package. Protect from light.
Do not use after expiry date which is stamped
on the pack. The expiry date refers to the last
day of that month. If the capsules show any
signs of discolouration or deterioration consult
your pharmacist for advice.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

(leaflet continued)

(leaflet continued overleaf)
4. Possible Side-Effects
Like all medicines, Phenytoin Hard Capsules
can cause side effects, although not everybody
gets them.
If you stop taking Phenytoin Hard Capsules
Do not stop taking Phenytoin Hard Capsules
unless your doctor tells you to. If you suddenly
stop taking this medicine you may have a
seizure. Should you need to stop taking
Phenytoin Hard Capsules, your doctor will have
decided which the best method is for you. If
you have any further questions on how to take
these Phenytoin Hard Capsules, ask your
doctor or pharmacist.
If you forget to take Phenytoin Hard
Capsules
If you forget to take a dose, take it as soon as
you remember unless it is time for your next
dose. Do not take a double dose to make up
for a missed dose.
If you take more Phenytoin Hard Capsules
than you should
Phenytoin Hard Capsules are dangerous in
overdose. If you accidentally take too many
Phenytoin Hard Capsules contact your doctor at
once or go to the nearest hospital casualty
department. Always take the labelled medicine
package with you, whether there is any
Phenytoin Hard Capsules left or not.
Elderly
The dose of Phenytoin Hard Capsules for
elderly patients who may be taking other
medicines may also need careful consideration
and adjustment by their doctor.
Always take Phenytoin Hard Capsules as your
doctor has told you. You should check with
your doctor or pharmacist if you are still not
sure.
Children
Infants and children usually start on a dose that
depends on their weight (5mg per day for every
kg they weigh) and is given as a divided dose,
twice a day. The dose is then adjusted up to a
maximum of 300 mg a day.

Tell your doctor immediately if you
experience any of the following symptoms after
taking this medicine. Although they are very
rare, these symptoms can be serious.
x Sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or
itching (especially affecting the whole
body).
x If you develop a severe skin rash that
causes blistering, (this can also affect the
mouth and tongue). These may be signs of
a condition known as Stevens Johnson
Syndrome, or toxic epidermal necrolysis
(TEN). Your doctor will stop your
treatment in these cases.
x If you notice bruising, fever, you are looking
pale or you have a severe sore throat.
These may be the first signs of an
abnormality of the blood, including
decreases in the number of red cells, white
cells or platelets. Your doctor may take
regular blood samples to test for these
effects.
x Skin rash and fever with swollen glands
particularly in the first two months of
treatment, as these may be signs of a
hypersensitivity reaction. If these are
severe and you also experience pain and
inflammation of the joints this could be
related to a condition called systemic lupus
erythematosus.
x If you experience a state of confusion or
have a severe mental illness, as this may
be a sign that you have high amounts of
phenytoin in your blood. On rare
occasions, when the amount of phenytoin in
the blood remains high, irreversible brain
injury has occurred.
Your doctor may test your blood to see how
much phenytoin is in the blood and may
change your dose.

Other side effects that may occur are:
x Effects on your nervous system:
Unusual eye movements, unsteadiness,
difficulty in controlling movements, shaking,
abnormal or uncoordinated movements,
slurred speech, confusion, pins and
needles or numbness, drowsiness,
dizziness, vertigo, sleeplessness,
nervousness, twitching muscles,
headaches and taste change.
x Effects on your skin: skin rash including
measles-like reactions which are mild.
x Effects on your stomach and intestines:
feeling sick, being sick and constipation.
x Effects on your blood and lymph
system: swelling of the lymph glands
x Effects on your liver and kidneys:
inflammation of the kidneys and liver, liver
damage (seen as yellowing of the skin and
whites of the eye).
x Effects on your reproductive system
and breasts: changes in the shape of the
penis, painful erection.
x Effects on hands, face and body:
changes in the hands with difficulty in
straightening the fingers, changes in facial
features, enlarged lips or gums, increased
or abnormal body or facial hair.
x Effects on medical tests: increased
levels of blood sugar, or decreased levels
of blood calcium, folic acid and vitamin D.
If you also do not get enough vitamin D in
your diet or from exposure to sunlight, you
may suffer from bone pain or fractures.
x Effects on your respiratory system:
problems breathing, inflammation of the
lining of the lung.
x Effects on your immune system:
problems with the body’s defence against
infection, inflammation of the wall of the
arteries.
x Effects on your bones: There have been
reports of bone disorders including
osteopenia and osteoporosis (thinning of
the bone) and fractures. Check with your
doctor or pharmacist if you are on longterm antiepileptic medication, have a
history of osteoporosis, or take steroids.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required, these measures will help to
protect the environment.
Remember: This medicine is only for you. Only
your doctor can prescribe Phenytoin Hard
Capsules for you. Never give it to anyone else.
They may harm them even if their symptoms
are the same as yours.
6. Further Information
What Phenytoin Hard Capsules contains
Each hard capsule is half white and half orange
marked with ‘Epanutin 100’ in black printing ink
containing white powder.
Each hard capsule contains 100mg of the
active ingredient phenytoin sodium.
The other ingredients are lactose monohydrate,
magnesium stearate, gelatin, sodium lauryl
sulphate, black printing ink, Titanium Dioxide
E171, erythrosine E127 and Quinoline Yellow
E104.
Contains a dessicant. The dessicant should not
be eaten.
Your medicine is available in pack of 100
capsules.
POM

PL 20774/1380
Phenytoin Hard Capsules

PACKAGE LEAFLET: INFORMATION FOR THE USER

PP1/1380/V2

Phenytoin Sodium Flynn 100mg Capsules
Epanutin® 100mg Hard Capsules
(phenytoin sodium)
Read all of this leaflet carefully before you
start taking this medicine
x Keep this leaflet. You may need to read it
again.
x If you have any further questions, ask your
doctor or pharmacist.
x This medicine has been prescribed for you.
Do not pass it onto others. It may harm
them, even if their symptoms are the same
as yours.
x If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
Your medicine is available in any of the above
two names, but will be referred to as
Phenytoin Hard Capsules throughout the
remainder of the leaflet.
In this leaflet:
1. What Phenytoin Hard Capsules are and what
they are used for.
2. Before you take Phenytoin Hard Capsules
3. How to take Phenytoin Hard Capsules
4. Possible side effects
5. How to store Phenytoin Hard Capsules
6. Further information
1. What Phenytoin Capsules are and what
they are used for.
Phenytoin Hard Capsules is one of a group of
medicines called anti-epileptic drugs; these
medicines are used to treat epilepsy.
Phenytoin Hard Capsules can be used to
control a variety of epileptic conditions, to
control or prevent seizures during or after brain
surgery or severe head injury. Phenytoin Hard
Capsules can also be used to treat trigeminal
neuralgia (facial nerve pain). You should ask
your doctor if you are unsure why you have
been given Phenytoin Hard Capsules.

2. Before you take Phenytoin Hard Capsules
Do not take Phenytoin Hard Capsules
x If you are allergic (hypersensitive) to
Phenytoin, or any of the other ingredients of
Phenytoin Hard Capsules
Take special care with Phenytoin Hard
Capsules
Medicines are not always suitable for everyone.
Your doctor needs to know before you take
Phenytoin Hard Capsules if you suffer from or
have suffered in the past from any of the
following conditions:
x Liver disease
x Porphyria (an inherited disease that affects
haemoglobin biosynthesis).
A small number of people being treated with
anti-epileptics such as phenytoin have had
thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately
contact your doctor.
Serious skin side effects can rarely occur
during treatment with Phenytoin Hard
Capsules. This risk may be associated with a
variant in genes in a subject of Chinese or Thai
origin. If you are of such origin and have been
tested positively carrying this generic variant
(HLA-B*1502), discuss this with your doctor
before taking Phenytoin Hard Capsules.
Taking other medicines
Some medicines can affect the way
Phenytoin Hard Capsules work, or
Phenytoin Hard Capsules itself can reduce
the effectiveness of other medicines taken
at the same time. These include:
x Medicines used for heart and circulation
problems (dicoumarol, digitoxin,
amiodarone, furosemide, quinidine,
reserpine, warfarin and calcium channel
blockers e.g. dilitazem and nifedipine.

(leaflet continued overleaf)

Adults
The amount of Phenytoin Hard Capsules
needed varies from one person to another.
Most adults need between 200 mg and 500 mg
a day, either as a single or divided dose.
Occasionally higher doses are needed.
3. How to take Phenytoin Hard Capsules
It is best to take Phenytoin Capsules at the
same time each day.
Swallow the capsules whole, with plenty of
water.
Important information about some of the
ingredients of Phenytoin Hard Capsules
Phenytoin Hard Capsules contain lactose, a
type of sugar. If you have been told that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.
Driving and using machines
Phenytoin Hard Capsules may cause dizziness
or drowsiness, especially during the first few
weeks of treatment. If you experience these
symptoms, do not drive or use any tools or
machinery.
Ask your doctor or pharmacist for advice before
taking any medicine.
You should not take Phenytoin Hard Capsules if
you are breast-feeding
Pregnancy and Breast-feeding
If you think you might be pregnant, or are
planning to get pregnant, tell your doctor before
you take Phenytoin Hard Capsules
Taking Phenytoin Hard Capsules with food
and drink
Phenytoin Hard Capsules can be taken before
or after food and drinks. Drinking a lot of
alcohol can also affect the concentration of
Phenytoin in your blood.
Phenytoin Hard Capsules may also interfere
with certain laboratory tests that you may be
given.
The herbal preparation St John’s wort
(Hypericum perforatum) should not be taken at
the same time as this medicine. If you already
take St John’s wort consult your doctor before
stopping St John’s wort preparation.

(leaflet continued)

5. How to store Phenytoin Hard Capsules
Keep out of the sight and reach of children
Do not store above 25°C. Store in the original
package. Protect from light.
Do not use after expiry date which is stamped
on the pack. The expiry date refers to the last
day of that month. If the capsules show any
signs of discolouration or deterioration consult
your pharmacist for advice.

Revision Date: 6th January 2014
Epanutin is a registered trademark of Parke,
Davis & Company LLC.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Medicines used for epilepsy
(carbamazepine, lamotrigine, phenobarbital,
sodium valproate and valproic acid,
succinimides e.g. ethosuximide and
vigabatrin).
x Medicines used to treat fungal infections
(e.g. amphotericin B, fluconazole,
itraconazole, ketoconazole and
miconazole).
x Medicines used for tuberculosis and other
infections (chloramphenicol, isoniazid,
rifampicin, sulphonamides, doxycycline and
ciprofloxacin and nelfinavir).
x Medicines used for stomach ulcers
(omeprazole, sucralfate, the medicines
known as H2 antagonists e.g. cimetidine,
ranitidine, famotidine and some antacids).
x Medicines used for asthma and bronchitis
(theophylline).
x Medicines used for pain and inflammation
(phenylbutazone, salicylates e.g. aspirin
and steroids).
x Medicines used for sleeplessness,
depression and psychiatric disorders
(chlorodiazepoxide, clozapine, diazepam,
disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, trazodone,
tricyclic antidepressants fluvoxamine,
sertraline and viloxazine).
x Medicines used for diabetes (tolbutamide).
x Some hormone replacement therapies
(oestrogens), oral contraceptives (the birth
control pill).
x Medicines used for organ tissue
transplants, to prevent rejection
(ciclosporin)
x Medicines used for cancer (antineoplastic
agents)
x Muscle relaxants used for surgery
(neuromuscular blockers), some
anaesthetic drugs (halothane) and
methadone
x Some products available without a
prescription folic acid, theophylline,
vitamin D).
Your doctor may need to test the amount of
Phenytoin in your blood to help decide if any of
these medicines are affecting your treatment.
x

(leaflet continued)

(leaflet continued overleaf)
4. Possible Side-Effects
Like all medicines, Phenytoin Hard Capsules
can cause side effects, although not everybody
gets them.
If you stop taking Phenytoin Hard Capsules
Do not stop taking Phenytoin Hard Capsules
unless your doctor tells you to. If you suddenly
stop taking this medicine you may have a
seizure. Should you need to stop taking
Phenytoin Hard Capsules, your doctor will have
decided which the best method is for you. If
you have any further questions on how to take
these Phenytoin Hard Capsules, ask your
doctor or pharmacist.
If you forget to take Phenytoin Hard
Capsules
If you forget to take a dose, take it as soon as
you remember unless it is time for your next
dose. Do not take a double dose to make up
for a missed dose.
If you take more Phenytoin Hard Capsules
than you should
Phenytoin Hard Capsules are dangerous in
overdose. If you accidentally take too many
Phenytoin Hard Capsules contact your doctor at
once or go to the nearest hospital casualty
department. Always take the labelled medicine
package with you, whether there is any
Phenytoin Hard Capsules left or not.
Elderly
The dose of Phenytoin Hard Capsules for
elderly patients who may be taking other
medicines may also need careful consideration
and adjustment by their doctor.
Always take Phenytoin Hard Capsules as your
doctor has told you. You should check with
your doctor or pharmacist if you are still not
sure.
Children
Infants and children usually start on a dose that
depends on their weight (5mg per day for every
kg they weigh) and is given as a divided dose,
twice a day. The dose is then adjusted up to a
maximum of 300 mg a day.

Tell your doctor immediately if you
experience any of the following symptoms after
taking this medicine. Although they are very
rare, these symptoms can be serious.
x Sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or
itching (especially affecting the whole
body).
x If you develop a severe skin rash that
causes blistering, (this can also affect the
mouth and tongue). These may be signs of
a condition known as Stevens Johnson
Syndrome, or toxic epidermal necrolysis
(TEN). Your doctor will stop your
treatment in these cases.
x If you notice bruising, fever, you are looking
pale or you have a severe sore throat.
These may be the first signs of an
abnormality of the blood, including
decreases in the number of red cells, white
cells or platelets. Your doctor may take
regular blood samples to test for these
effects.
x Skin rash and fever with swollen glands
particularly in the first two months of
treatment, as these may be signs of a
hypersensitivity reaction. If these are
severe and you also experience pain and
inflammation of the joints this could be
related to a condition called systemic lupus
erythematosus.
x If you experience a state of confusion or
have a severe mental illness, as this may
be a sign that you have high amounts of
phenytoin in your blood. On rare
occasions, when the amount of phenytoin in
the blood remains high, irreversible brain
injury has occurred.
Your doctor may test your blood to see how
much phenytoin is in the blood and may
change your dose.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.